Squamous Cell Carcinoma Clinical Trial
Official title:
A Biomarker-implemented Clinical Study Evaluating Mutations in MET and TP53 in a Population of Treatment-refractory Squamous Cell Carcinoma
Afatinib is approved therapy for SCC of the lung after progression with standard of care chemotherapy. There is also evidence of improvement of progression free survival of patients with metastatic/recurrent SCC of the head and neck after failure of chemotherapy in patients treated with afatinib. Therefore, treatment of patients with these 2 conditions with afatinib is not experimental, and will follow conventional clinical management.
Clinical objectives:
1. To determine the efficacy of afatinib in patients with germline MET-N375S polymorphism.
2. To determine the tolerability of afatinib in chemo-relapsed patients with germline
MET-N375S polymorphism.
Research objectives:
1. To determine the prevalence of MET and TP53 mutations, as well as HER2 and MET
amplification, in various cancers, particularly head and neck cancers and lung cancers.
2. To establish tumour cell lines, spheroids of xenografts for drug screening.
Endpoints of study:
1. To determine the response rate of SCC HN/lung with Met-N375S to afatinib.
2. The secondary endpoints include progression-free survival and toxicity.
3. Frequency of MET mutations and TP53 mutations in patients with cancer.
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